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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 10/17/2018
Event Type  Injury  
Manufacturer Narrative
There was no patient involvement. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Through follow-up communication with the chief perfusionist under previous cases from this hospital, livanova (b)(4) learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry. This is not in alignment with current instruction for use however reportedly the devices in use at the hospital are very clean and there is no sign of biofilm. The devices are located inside the operating theatre during use. The serial numbers of the device used for this surgery is unknown. However, two (2) over five (5) devices used at the hospital resulted to be contaminated. Only one serial number has been provided (b)(4) and a follow up report for the other cases associated to this specific device has been filed. The second serial number remains unknown as well as the type of contamination. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received a report of a female patient infected with mycobacterium chimaera at (b)(6) medical center. The patient underwent replacement graft of ascending aorta and suspension of aortic valve surgery in (b)(6) 2018. Reportedly, the patient began showing signs of systemic infection in her body. The serial number of the device used is unknown. The patient is currently on long term antibiotics. This event was initially captured under importer report number 1718850 -2020-01097 and manufacturer report number 9611109 -2020 -00374 and then splitted following to additional information received.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
MDR Report Key10983617
MDR Text Key220672736
Report Number1718850-2020-01216
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-02-85
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/12/2020
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 12/10/2020 Patient Sequence Number: 1
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